Antibody rapid test is an immunoassay intended for the qualitative detection and differentiation of IgG and IgM from the SARS-CoV-2 in plasma from anticoagulated human blood (heparin/ EDTA/ sodium citrate) or serum from individuals with signs and symptoms of infection who are suspected of COVID-19 infection by a healthcare provider. The test is an aid to be used in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.
Negative results do not preclude SARS-CoV-2 virus infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected during the first few days of infection; the sensitivity of the test early after infection is unknown. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 coronavirus strains.
False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
At this time, it is unknown for how long IgM or IgG antibodies may persist following infection.
This test is not intended for the screening of donated blood.
Test is only used as a supplementary test for suspected SARS-CoV-2 infection which is detected negative nucleic acid or it was used in conjunction with nucleic acid detection in the diagnosis of suspected cases. And it cannot be used for screening in the general population.